FDAnews Device Daily Bulletin

A majority of devicemakers are unhappy with the way CDRH handles 510(k) submissions, according to a study by the Minnesota Medical Device Alliance.

First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, received an FDA warning letter related to design control failures and other quality system violations.

Orthofix International NV, has agreed to pay the United States $30 million to settle allegations that an Orthofix subsidiary, Blackstone Medical Inc., paid illegal kickbacks to physicians in order to induce use of the company’s products, the Justice Department announced today.

St. Jude Medical, a medical device company based in Little Canada, Minn., announced that its EnligHTN renal denervation system safely and effectively lowered blood pressure at six months.

Radiosurgery systems maker, Accuray, recently received FDA 510(k) approval for its new Cyberknife M6 Series.

The FDA issued a second warning to light-based therapy devices maker The Avalon Effect for unregulated claims that its devices can cure or treat symptoms of fungal meningitis, MRSA, concussions, Lyme disease and other diseases.

Sorin announced today the U.S. commercial launch of the Mitroflow Valsalva Conduit, the only Valsalva conduit graft approved by the FDA for use in combination with an aortic tissue valve.

Could this only happen in Minnesota? The 71-year-old CEO of Techne, a public, Minneapolis-based life sciences company whose products are used by hospitals and the medical research industry, has abruptly resigned his position as the top executive and chairman of the board.